B-cell Acute Lymphoblastic LeukemiaPhase 2/3NCT07570173
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
A Phase 2/3 study testing MK-1045, Blinatumomab and Acetaminophen in people with B-cell Acute Lymphoblastic Leukemia, run by Merck Sharp & Dohme LLC at 27 sites in 10 countries.
Trial summary
Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- MK-1045, Blinatumomab and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 27 sitesin 10 countries
- Study dates
- 18 May 2026to 18 Oct 2033
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow
- Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment
- Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment
- Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Who cannot join
- Has Burkitt's leukemia
- History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis
- Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded
- History of serious cardiovascular and cerebrovascular diseases.
- HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment
Show all 12Show fewer
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Isolated extramedullary disease (EMD)
- Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement
- Active infection requiring systemic therapy
- Has not adequately recovered from major surgery or have ongoing surgical complications
Trial locations and contacts
27 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 10 countries
Greece5 sites, 5 recruiting
- Recruiting
Evangelismos General Hospital of Athens ( Site 5100)
Athens, Attica, 106 76
Study Coordinator, 00302132041
- Recruiting
General Hospital of Athens "Laiko" ( Site 5101)
Athens, Attica, 115 27
Study Coordinator, +302132061702
- Recruiting
General Hospital of Athens "Laiko" ( Site 5104)
Athens, Attica, 115 27
Study Coordinator, +302132061643
- Recruiting
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5102)
Chaïdári, Attica, 124 62
Study Coordinator, +30 2105832318
- Recruiting
University Hospital of Ioannina ( Site 5103)
Ioannina, 455 00
Study Coordinator, +302651099656
Spain5 sites, 5 recruiting
- Recruiting
Institut Català d'Oncologia (ICO) - Badalona ( Site 3001)
Badalona, Barcelona, 08916
Study Coordinator, +34934978387
- Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)
Madrid, 28233
Study Coordinator, +34914521900
- Recruiting
Hospital Universitario Central de Asturias ( Site 3008)
Oviedo, Principality of Asturias, 33011
Study Coordinator, +34985108000
- Recruiting
Clinica Universidad de Navarra ( Site 3006)
Pamplona, Navarre, 31008
Study Coordinator, +34948255400
- Recruiting
Hospital Universitario de Salamanca ( Site 3002)
Salamanca, 37007
Study Coordinator, +34923291100
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0903)
Haifa, 3109601
Study Coordinator, +97247772547
- Recruiting
Haddasah Medical Center ( Site 0900)
Jerusalem, 9112001
Study Coordinator, 97226777333
- Recruiting
Sheba Medical Center ( Site 0902)
Ramat Gan, 5265601
Study Coordinator, +97235308401
- Recruiting
Sourasky Medical Center. ( Site 0904)
Tel Aviv, 6423906
Study Coordinator, +97237772647
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)
Aarhus Nord, Central Jutland, 8200
Study Coordinator, +4578450000
- Recruiting
Rigshospitalet ( Site 0802)
Copenhagen, Capital Region, 2100
Study Coordinator, +45 35455375
- Recruiting
Odense Universitetshospital ( Site 0801)
Odense C, Region Syddanmark, 5000
Study Coordinator, +45 66113333
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC ( Site 2001)
Amsterdam, North Holland, 1081 HV
Study Coordinator, +31204443628
- Recruiting
Radboud UMC ( Site 2003)
Geert Grooteplein-Zuid 8, Gelderland, 6500 HB
Study Coordinator, 0243618800
- Recruiting
Erasmus Medisch Centrum ( Site 2000)
Rotterdam, South Holland, 3015 GD
Study Coordinator, +31107033123
Italy2 sites, 2 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1002)
Bergamo, Lombardy, 24127
Study Coordinator, 00390352673681
- Recruiting
Policlinico Universitario Agostino Gemelli ( Site 1003)
Rome, Roma, 00168
Study Coordinator, 00390630154968
Japan2 sites, 2 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital ( Site 2106)
Bunkyo, Tokyo, 113-8677
Study Coordinator, +81-3-3823-2101
- Recruiting
Toranomon Hospital ( Site 2101)
Minato, Tokyo, 105-8470
Study Coordinator, +81-3-3588-1111
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center ( Site 0102)
Toronto, Ontario, M5G 2M9
Study Coordinator, 416-946-4501
France1 site, 1 recruiting
- Recruiting
Hopital Saint-Louis ( Site 4100)
Paris, Île-de-France Region, 75010
Study Coordinator, +33157276717
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset ( Site 4002)
Stockholm, Stockholm County, 171 76
Study Coordinator, +46812379740
About this study
Official title: A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.
Read the detailed description
This study has 2 parts: Part 1 is a dose optimization phase of MK-1045. Part 2 is a randomized phase comparing the efficacy and safety of MK-1045 versus blinatumomab and will use the recommended dose of MK-1045 determined in Part 1
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- MK-1045, Blinatumomab, Acetaminophen, Diphenhydramine, Dexamethasone
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1045Biological
Intravenous administration
BlinatumomabBiological
Intravenous administration
AcetaminophenDrug
Oral administration as a premedication
DiphenhydramineDrug
Intravenous administration as a premedication
DexamethasoneDrug
Intravenous administration as a premedication
TocilizumabDrug
Intravenous administration as a rescue medication
SiltuximabDrug
Intravenous administration as a rescue medication
AvtozmaDrug
Intravenous administration as a rescue medication
TyenneDrug
Intravenous administration as a rescue medication
| Study group | Role | What they receive |
|---|---|---|
| MK-1045 Dose Regimen A | Experimental | Participants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1. Receives: Biological: MK-1045; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne |
| MK-1045 Dose Regimen B | Experimental | Participants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1. Receives: Biological: MK-1045; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne |
| Blinatumomab | Active comparator | Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle Receives: Biological: Blinatumomab; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Overall Survival (OS) in Study Part 2
OS is the time from randomization to death due to any cause.
Measured: Up to approximately 7 years
Secondary outcomes (11)
Overall survival (OS) in Study Part 1
OS is the time from randomization to death due to any cause.
Measured: Up to approximately 7 years
Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2
MRD is defined as no detectable leukemia cells below a threshold of at least 10^-4.
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Percentage of Participants that achieve CR/CR with partial hematologic recovery (CRh)/CR with incomplete count recovery (CRi) in Study Part 1 and Part 2
For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).
CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets <100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC <1000/μL.
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Percentage of Participants with CR or CRh in Study Part 2
The percentage of participants who meet either CR or CRh requirements will be presented.
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).
Measured: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)
Duration of CR (DOR-CR) in Study Part 2
For participants who demonstrate CR, duration of remission is defined as the time from the first documented evidence of CR until disease progression, relapse, or death due to any cause, whichever occurs first.
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
Measured: Up to approximately 7 years
Duration of CR/CRh (DOR-CR/CRh) in Study Part 2
For participants who demonstrate CR or CRh, duration of remission is defined as the time from the first documented evidence of CR or CRh (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).
Measured: Up to approximately 7 years
Duration of CR/CRh/CRi (DOR-CR/CRh/CRi) in Study Part 2
For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.
CR is defined as:
- No circulating lymphoblasts
- Extramedullary disease negative
- Trilineage hematopoiesis (TLH) and <5% leukemic blasts
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelets ≥100,000/μL
- No platelet transfusions in the last 7 days
- No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).
CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets <100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC <1000/μL.
Measured: Up to approximately 7 years
Event Free Survival (EFS) in Study Part 2
The time from randomization to the first documented disease progression, relapse, or death due to any cause, whichever occurs first.
Measured: Up to approximately 7 years
Percentage of participants that proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Study Part 2
The use of allo-HSCT treatment after randomization.
Measured: Up to approximately 7 years
Percentage of Participants Who Experience an AE in Study Part 2
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.
Measured: Up to approximately 7 years
Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 2
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start18 May 2026
- Primary completion18 Oct 2033 (estimated)
- Study completion18 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570173
- Sponsor's protocol ID
- 1045-005
- Other IDs
- MK-1045-005, 2025-522267-15-00, U1111-1322-4387, jRCT2031260140, 2025
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf